The respective provision regarding the supply of free samples is Article 96 Para 1 which addresses solely the supply to prescribing persons and provides for certain conditions for such supply. The Federal Supreme Court had doubts whether the German provision was in line with the Community code relating to medicinal products for human use (Directive 2001/83/EC, in the following “ Community Code”). Referral to the CJEU by the German Federal Supreme Court Pharmacists were not included in the list, so the courts considered the supply to them to be illegal. The courts concluded that Section 47 Para 3 of the AMG exhaustively listed the persons to whom free drug samples could be provided, namely specific groups, all of whom were entitled to prescribe prescription drugs. The action was successful in first instance and appeal. The other company considered this to be in violation of the German Medicines Act (" AMG"), resulting in a breach of competition law (“unfair advantage via legal violation”, “Vorsprung durch Rechtsbruch”). One of the companies had supplied free samples to pharmacists "for demonstration purposes”.
The legal dispute which led to the decision of the CJEU was an unfair competition lawsuit between two pharmaceutical companies selling non-prescription pain gel.
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